# K990907: Remote Introducer, Model PI-1000

- Pathway: 510(k) (Traditional)
- Applicant: Image-Guided Neurologics, Inc.
- Decided: Aug 12, 1999 after 147 days
- Product code: HAW (Neurological Stereotaxic Instrument)
- Device class: 2
- Regulation: 21 CFR 882.4560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Remote Introducer is intended to provide stereotactic delivery of neurosurgical instruments or devices during planning and operation of neurological procedures within the MRI environment and in conjunction with MR imaging and guidance using the Navigus Trajectory Guide. These procedures include catheter placement and electrode implant.

Source page: https://510kreport.com/device/K990907
Methodology: https://510kreport.com/methodology